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European Commission approves SmPC update for VIRAMUNE in HIV treatment

Boehringer Ingelheim announced today that the European Commission has approved an update to the Summary of Product Characteristics (SmPC) for VIRAMUNE (nevirapine) in the treatment of patients with HIV.

16 Sep 2010

GSK, Genmab to refocus on ofatumumab development program in autoimmune indications

GlaxoSmithKline and Genmab A/S Following the 1st July announcement by GSK and Genmab of an amendment to the collaborative agreement for ofatumumab in which GSK assumed development responsibility for autoimmune indications, GSK and Genmab announced today plans to refocus the development program of ofatumumab in autoimmune indications.

16 Sep 2010

Tetraphase Pharmaceuticals presents preclinical data of TP-434 antibacterial drug

Tetraphase Pharmaceuticals, Inc., today presented encouraging preclinical data for its lead drug candidate, TP-434, which showed the potent antibacterial activity of TP-434 against a very broad spectrum of susceptible and multidrug-resistant pathogens.

16 Sep 2010

Researchers find NCT analogs show antimicrobial, anticoagulant activity

Catheter-related bacteremia can be a significant cause of sickness and death for hemodialysis patients. The anticoagulant heparin is commonly used as a catheter lock solution to prevent thrombosis; however has limited antimicrobial activity.

16 Sep 2010

ASG-5ME compound kills pancreatic cancer cells: Researchers

A new investigational drug designed to penetrate and attack pancreatic cancer cells has been administered to a patient for the first time ever at the Virginia G. Piper Cancer Center at Scottsdale Healthcare.

16 Sep 2010

JAK oral medication produces lasting relief for patients with myelofibrosis: Researchers

An oral medication produces significant and lasting relief for patients with myelofibrosis, a debilitating and lethal bone marrow disorder, researchers at The University of Texas MD Anderson Cancer Center report in the Sept. 16 New England Journal of Medicine.

16 Sep 2010

K.U.Leuven enters license agreement with Pfizer to commercialize anti-HIV drugs

K.U.Leuven announced today that on July 29th, 2010 they entered into a license agreement with Pfizer. The license agreement grants Pfizer exclusive and sublicenseable worldwide rights to further develop and commercialise K.U.Leuven's compounds with a new mechanism of action for the potential treatment of individuals infected with HIV, the virus that causes AIDS.

16 Sep 2010

FDA updates dosing recommendation for Valcyte medication

The U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant.

16 Sep 2010

Researchers investigate antimicrobial activity of Aganocide compounds against H1N1

Fears over the influenza A virus (H1N1; sometimes referred to as swine flu) have motivated researchers to investigate the antimicrobial activity of the Aganocide compounds against viruses. In a study presented at this year's Interscience Conference on Antimicrobial Agents and Chemotherapy, a team led by Professor Markus Nagl, MD of Medical University of Innsbruck and including D. Debabov, PhD and K. Hybiske, PhD of NovaBay Pharmaceuticals evaluated the in vitro virucidal activity of three compounds: N-chlorotaurine, a compound produced by human phagocytes; and two NCT analogs, NVC-612 and NVC-422.

16 Sep 2010

Access Pharmaceuticals launches product website for MuGard

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company specializing in products for cancer and supportive care, announced today it has launched www.MuGard.com. The patient- and healthcare professional- focused site is a comprehensive resource offering educational material on oral mucositis, patient analysis, MuGard product and how-to-order information.

15 Sep 2010

Bruner to encourage FDA advisory committee to consider effectiveness of obesity drug Lorcaserin

On September 16, Denise Bruner, MD, FASBP will speak in favor of FDA approval for the new obesity drug Lorcaserin, during the open public hearing hour at the Endocrinologic and Metabolic Drug Advisory Committee meeting.

15 Sep 2010

Bohai adds additional pharmaceutical products to Traditional Chinese Medicine portfolio

Bohai Pharmaceuticals Group, Inc., a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, today announced the introduction of five additional pharmaceutical products to its portfolio of TCM offerings.

15 Sep 2010

Abstract on ACH-1625 accepted as late breaking poster presentation at The Liver Meeting 2010

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced that its abstract titled "ACH-1625 Demonstrates Sustained Viral Suppression in Presence of Uncommon Drug Resistant HCV Variants: Pharmacokinetic, Pharmacodynamic and Clinical Virology Analysis of Phase I Study" has been accepted as a late breaking poster presentation at the 61st Annual Meeting of the American Association for the Study of Liver Disease The Liver Meeting 2010 being held October 29-November 2, 2010 in Boston.

15 Sep 2010

Oramed Pharmaceuticals announces clinical trial results of ORMD-0801 capsule in Type I diabetics

Oramed Pharmaceuticals Inc. announced today successful results in an exploratory clinical trial testing the effectiveness of its oral insulin capsule (ORMD-0801) in Type I diabetes patients suffering from uncontrolled diabetes.

15 Sep 2010

FDA extends PDUFA date for AstraZeneca's ticagrelor NDA

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for ticagrelor (BRILINTA).

15 Sep 2010

MVI agrees to provide fund for evaluating Inovio's malaria DNA vaccine candidate in non-human primates

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that the PATH Malaria Vaccine Initiative (MVI) has agreed to provide follow-on funding to continue evaluation and development of Inovio's malaria DNA vaccine candidate in non-human primates.

15 Sep 2010

Elsevier launches new Pharmacokinetics Module of PharmaPendium

Elsevier today announces that it has significantly increased its service offering to pharmaceutical R&D professionals with the launch of a new Pharmacokinetics Module of PharmaPendium-, the online resource for authoritative drug development data.

15 Sep 2010

$Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy$

Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy

Savient Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA™ (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

15 Sep 2010

FDA approves Krystexxa drug to treat gout

The U.S. Food and Drug Administration approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.

15 Sep 2010

Apricus Biosciences announces reformulation of Rituxan enables rectal delivery of biologics

Apricus Biosciences, backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT drug delivery technology and internal pipeline through out-licensing arrangements and partnerships, today announced results from a pre-clinical pharmacokinetic study showing the ability of NexACT to enable rectal delivery of biologics, such as human antibodies.

15 Sep 2010

Pharmaceutical News

European Commission approves SmPC update for VIRAMUNE in HIV treatment

GSK, Genmab to refocus on ofatumumab development program in autoimmune indications

Tetraphase Pharmaceuticals presents preclinical data of TP-434 antibacterial drug

Researchers find NCT analogs show antimicrobial, anticoagulant activity

ASG-5ME compound kills pancreatic cancer cells: Researchers

JAK oral medication produces lasting relief for patients with myelofibrosis: Researchers

K.U.Leuven enters license agreement with Pfizer to commercialize anti-HIV drugs

FDA updates dosing recommendation for Valcyte medication

Researchers investigate antimicrobial activity of Aganocide compounds against H1N1

Access Pharmaceuticals launches product website for MuGard

Bruner to encourage FDA advisory committee to consider effectiveness of obesity drug Lorcaserin

Bohai adds additional pharmaceutical products to Traditional Chinese Medicine portfolio

Abstract on ACH-1625 accepted as late breaking poster presentation at The Liver Meeting 2010

Oramed Pharmaceuticals announces clinical trial results of ORMD-0801 capsule in Type I diabetics

FDA extends PDUFA date for AstraZeneca's ticagrelor NDA

MVI agrees to provide fund for evaluating Inovio's malaria DNA vaccine candidate in non-human primates

Elsevier launches new Pharmacokinetics Module of PharmaPendium

Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy

FDA approves Krystexxa drug to treat gout

Apricus Biosciences announces reformulation of Rituxan enables rectal delivery of biologics

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

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